Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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13mm Segmental Rigid Plate
OSTEOMED LLC
210-0308
In Commercial Distribution

  • 00845694015820 ()

  • Span Length = 13mm
210-0308

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Extended (1.16") Driver Stem, OsteoDriver™
OSTEOMED LLC
450-0619
In Commercial Distribution

  • 00845694015738 ()
450-0619

  • Surgical screwdriver, reusable
1.6mm Low Profile, X-Large Bur Hole Plate
OSTEOMED LLC
218-0096
In Commercial Distribution

  • 00845694014953 ()

  • Outer Diameter: 31 Millimeter
218-0096

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Low Profile, Large Bur Hole Plate
OSTEOMED LLC
218-0095
In Commercial Distribution

  • 00845694014946 ()

  • Outer Diameter: 26 Millimeter
218-0095

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Low Profile Small Bur Hole Plate
OSTEOMED LLC
218-0094
In Commercial Distribution

  • 00845694014939 ()

  • Outer Diameter: 19 Millimeter
218-0094

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Low Profile Long 2 Hole Straight Plate
OSTEOMED LLC
218-0093
In Commercial Distribution

  • 00845694014922 ()

  • Length: 18 Millimeter
218-0093

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Low Profile Medium 2 Hole Straight Plate
OSTEOMED LLC
218-0092
In Commercial Distribution

  • 00845694014915 ()

  • Length: 14 Millimeter
218-0092

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Low Profile Short2 Hole Straight Plate
OSTEOMED LLC
218-0091
In Commercial Distribution

  • 00845694014908 ()

  • Length: 10 Millimeter
218-0091

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm, Low Profile 9mm Square Plate
OSTEOMED LLC
218-0090
In Commercial Distribution

  • 00845694014892 ()

  • Length: 13 Millimeter
218-0090

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bur Hole Shunt Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0061-SP
In Commercial Distribution

  • 00845694014885 ()

  • Outer Diameter: 26 Millimeter
218-0061-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Large Bur Hole Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0034-SP
In Commercial Distribution

  • 00845694014878 ()

  • Outer Diameter: 26 Millimeter
218-0034-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Small Bur Hole Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0032-SP
In Commercial Distribution

  • 00845694014861 ()

  • Outer Diameter: 18 Millimeter
218-0032-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Double Y Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0028-SP
In Commercial Distribution

  • 00845694014854 ()

  • Length: 18 Millimeter
218-0028-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Long 2 Hole Straight Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0026-SP
In Commercial Distribution

  • 00845694014847 ()

  • Length: 17 Millimeter
218-0026-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Medium 2 Hole Straight Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0024-SP
In Commercial Distribution

  • 00845694014830 ()

  • Length: 13 Millimeter
218-0024-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
9mm Square Plate, Sterile, 5 Pack
OSTEOMED LLC
218-0020-SP
In Commercial Distribution

  • 00845694014823 ()

  • Length: 13 Millimeter
218-0020-SP

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Rigid Comminuted Fracture Plate
OSTEOMED LLC
214-0221
In Commercial Distribution

  • 00845694014724 ()

  • Thickness = 2.0mm
214-0221

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.2mm Extended Driver Stem, OsteoDriver™
OSTEOMED LLC
450-0620
In Commercial Distribution

  • 00845694013000 ()
450-0620

  • General internal orthopaedic fixation system implantation kit
2.0mm Extended Driver Stem, OsteoDriver™
OSTEOMED LLC
450-0603
In Commercial Distribution

  • 00845694012843 ()
450-0603

  • General internal orthopaedic fixation system implantation kit
2.0mm Driver Stem, OsteoDriver™
OSTEOMED LLC
450-0602
In Commercial Distribution

  • 00845694012836 ()
450-0602

  • General internal orthopaedic fixation system implantation kit
1.6mm Driver Stem, OsteoDriver™
OSTEOMED LLC
450-0601
In Commercial Distribution

  • 00845694012829 ()
450-0601

  • Surgical screwdriver, reusable
1.6mm Screwdriver Shaft, Manual
OSTEOMED LLC
220-0061
In Commercial Distribution

  • 00845694005883 ()
220-0061

  • Surgical screwdriver, reusable
DRIVER X1205032 PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X1205032
In Commercial Distribution

  • 00613994583543 ()


  • Surgical drill guide, reusable
HAMMER X3986550 FORK
MEDTRONIC SOFAMOR DANEK, INC.
X3986550
In Commercial Distribution

  • 00613994582980 ()


  • Surgical mallet
LOCK SCREW DRIVER 7080930 TRI-FLAT
MEDTRONIC SOFAMOR DANEK, INC.
7080930
In Commercial Distribution

  • 00613994582713 ()


  • Surgical screwdriver, reusable
DRIVER X0109691 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
X0109691
In Commercial Distribution

  • 00613994568120 ()


  • Orthopaedic implant driver
DRIVER 7579323 SEXTANT 2 REDUCTION M8
MEDTRONIC SOFAMOR DANEK, INC.
7579323
In Commercial Distribution

  • 00613994565808 ()


  • Surgical screwdriver, reusable
DRIVER 7578196 SEXTANT 2 FOR M8
MEDTRONIC SOFAMOR DANEK, INC.
7578196
In Commercial Distribution

  • 00613994565778 ()


  • Surgical screwdriver, reusable
COMPRESSOR 7578195 SEXTANT 2 FOR M8
MEDTRONIC SOFAMOR DANEK, INC.
7578195
In Commercial Distribution

  • 00613994565761 ()


  • Surgical screwdriver, reusable
CASE 1859026 LEGACY6.35 NAV DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
1859026
In Commercial Distribution

  • 00613994560568 ()


  • Instrument tray, reusable
FPS 3.5/4.0mm Driver Stem
OSTEOMED LLC
323-1035
In Commercial Distribution

  • 00845694021807 ()
323-1035

  • General internal orthopaedic fixation system implantation kit
FPS 2.7mm Driver Stem
OSTEOMED LLC
323-1024
In Commercial Distribution

  • 00845694021791 ()
323-1024

  • General internal orthopaedic fixation system implantation kit
FPS 2.0mm Driver Stem
OSTEOMED LLC
323-1020
In Commercial Distribution

  • 00845694021784 ()
323-1020

  • General internal orthopaedic fixation system implantation kit
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, 5 x 16 Hole, Left
OSTEOMED LLC
214-2420
In Commercial Distribution

  • 00845694016803 ()

  • Thickness = 2.5mm
214-2420

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, 5 x 16 Hole, Right
OSTEOMED LLC
214-2419
In Commercial Distribution

  • 00845694016797 ()

  • Thickness = 2.5mm
214-2419

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, 18 Hole
OSTEOMED LLC
214-2418
In Commercial Distribution

  • 00845694016780 ()

  • Thickness = 2.5mm
214-2418

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, 14 Hole
OSTEOMED LLC
214-2417
In Commercial Distribution

  • 00845694016773 ()

  • Thickness = 2.5mm
214-2417

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, Left 5 x 16 x 5 Hole
OSTEOMED LLC
214-2416
In Commercial Distribution

  • 00845694016766 ()

  • Thickness = 2.5mm
214-2416

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, Left 5 x 20 x 5 Hole
OSTEOMED LLC
214-2415
In Commercial Distribution

  • 00845694016759 ()

  • Thickness = 2.5mm
214-2415

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, 4 x 12 Hole, Left
OSTEOMED LLC
214-2414
In Commercial Distribution

  • 00845694016742 ()

  • Thickness = 2.5mm
214-2414

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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